Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-31 @ 4:58 AM
Study NCT ID:
NCT04609956
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery (VIDAMO)
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Comparative Randomized Study of Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIDAMO
Brief Summary:
For a long time, the fear of the dental surgeon has been the main reason why a percentage of the population avoids regular consultation.
There are many techniques to manage anxiety (tell-show-do, positive reinforcement, live modeling, etc). Now, virtual reality offers this possibility as a non-drug alternative technique.
Few studies have assessed the value of virtual reality in peroperative during an oral surgery procedure.
It is interesting to compare the immediate post-operative anxiety level between groups using virtual reality headset (RV) versus standard protocol (hydroxyzine + music with headphones : SMP)
There are many techniques to manage anxiety (tell-show-do, positive reinforcement, live modeling, etc). Now, virtual reality offers this possibility as a non-drug alternative technique.
Few studies have assessed the value of virtual reality in peroperative during an oral surgery procedure.
It is interesting to compare the immediate post-operative anxiety level between groups using virtual reality headset (RV) versus standard protocol (hydroxyzine + music with headphones : SMP)
Detailed Description:
Anxiety is defined as a state of psychic disorder caused by fear of danger ; pain as an unpleasant sensory and emotional experience. Although pain and anxiety are subjective sensations, oral cavity care is very much associated with these perceptions.
Thus, the fear of the oral health practitioner (dental surgeon, oral surgeon, maxillofacial surgeon, etc.) is one of the main reasons why a large part of the population does not consult. This real phobia installed in people's imaginary is partly explained by the fact that the mouth is an intimate part of the body. Indeed, according to the Freudian theory, discovery of body and sexuality begins with the oral stage with the oral and esophageal sphere favored as an erogenous zone (supported by the motor activity of sucking). In this way, the oral cavity is a place of love privacy and erotic intimacy, but also a means of communication and a means of recognizing tastes. Regular consultation with a specialist is consequently essential since good oral hygiene is a source of well-being (notions of pleasure, satisfaction).
Oral health practitioners have many solutions in order to reduce patients' apprehension of anxiety and their painful perceptions. In addition to the psychological approach and cognitive-behavioral therapy (tell-show-do, adapt vocabulary, involve the patient in the therapeutic project) ; medical means are available to the practitioner. According to the therapeutic gradient: firstly use of anxiolytics (hydroxyzine) more or less associated with music therapy or other methods of distraction, conscious sedation (Equimolar mixture of Oxygen and Nitrous Oxide - EMONO) and as a last resort general anesthesia.
An alternative non-drug technique has increased : the use of virtual reality (VR). This new technology, recognized for its entertainment value (creation of virtual environments that immerse people in a simulated world) has been extended to other fields including health, particularly for pain and anxiety management.
Thus, the fear of the oral health practitioner (dental surgeon, oral surgeon, maxillofacial surgeon, etc.) is one of the main reasons why a large part of the population does not consult. This real phobia installed in people's imaginary is partly explained by the fact that the mouth is an intimate part of the body. Indeed, according to the Freudian theory, discovery of body and sexuality begins with the oral stage with the oral and esophageal sphere favored as an erogenous zone (supported by the motor activity of sucking). In this way, the oral cavity is a place of love privacy and erotic intimacy, but also a means of communication and a means of recognizing tastes. Regular consultation with a specialist is consequently essential since good oral hygiene is a source of well-being (notions of pleasure, satisfaction).
Oral health practitioners have many solutions in order to reduce patients' apprehension of anxiety and their painful perceptions. In addition to the psychological approach and cognitive-behavioral therapy (tell-show-do, adapt vocabulary, involve the patient in the therapeutic project) ; medical means are available to the practitioner. According to the therapeutic gradient: firstly use of anxiolytics (hydroxyzine) more or less associated with music therapy or other methods of distraction, conscious sedation (Equimolar mixture of Oxygen and Nitrous Oxide - EMONO) and as a last resort general anesthesia.
An alternative non-drug technique has increased : the use of virtual reality (VR). This new technology, recognized for its entertainment value (creation of virtual environments that immerse people in a simulated world) has been extended to other fields including health, particularly for pain and anxiety management.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: